This refers to the NRC inspection conducted on July 21-22, 1997 at your
facility in Willimantic, Connecticut, and continued in the Region I office
on August 6, 1997 to review information telephonically provided to Mr.
Louis Manning, NRC Region I, by Dr. Robert Daly, your Radiation Safety
Officer (RSO) on that date. During the inspection, the circumstances associated
with the falsification of dose calibrator constancy records were reviewed.
This falsification was identified by your staff and reported to the NRC.
Also, other apparent violations of NRC requirements were identified by
the NRC, and were described in the related inspection report sent to you
on September 8, 1997. On September 25, 1997, a Predecisional Enforcement
Conference (conference) was conducted with you and members of your staff
to discuss the violations, their causes, and corrective actions. A copy
of the enforcement conference report was sent to you by separate correspondence
on November 12, 1997.

Based on the information developed during the inspection, and the information
provided during the conference, the NRC has determined that violations
of NRC requirements occurred. The violations are cited in the enclosed
Notice of Violation (Notice) and the circumstances surrounding them are
described in detail in the subject inspection report and the transcript
of the conference. The most significant violations, which were identified
by your staff and reported to the NRC, involved the creation of false
records, namely: (1) the creation of approximately two months of inaccurate
records of the daily dose calibrator constancy test by a former Nuclear
Medicine Technologist (NMT); and (2) the creation of inaccurate records
associated with the disposal of aerosol kits by the NMT Supervisor. These
records are required pursuant to 10 CFR 35.50, "Possession, use, calibration,
and check of dose calibrators", and 10 CFR 35.92, "Decay-in-storage."
These records are required to be complete and accurate pursuant to 10
CFR 30.9, "Completeness and accuracy of information."

Specifically, between March 10, 1997 and May 12, 1997, while the former
NMT acted for the NMT Supervisor who was on extended leave, the NMT did
not perform the required daily constancy tests of the cobalt-57 source
with the dose calibrator, yet entered data into the record to indicate
that the tests had been performed. Later, the NMT changed the data after
the NMT Supervisor returned and noticed that it was not within the acceptable
range. The new entries were fabrications as well. Additionally, as you
related at the conference, your investigation determined that the NMT
supervisor, upon his return from extended leave in May 1997, fabricated
records of dates to document the disposal of radioactive aerosol kits
that were held for decay-in-storage during the period when he was on medical
leave. The NMT Supervisor could not have had first-hand knowledge of these
dates because he had been on medical leave.

The NRC recognizes that you identified these findings and also took a
number of corrective actions, including the termination of the NMT, and
demotion of the NMT Supervisor to an NMT. Nonetheless, the falsification
of NRC required records is a serious regulatory concern since the entire
regulatory process is based on the integrity of the staff carrying out
licensed activities. The NRC is also concerned that the RSO, as he admitted
during the inspection, did not normally review the "day-to-day" operations
of your program, and did not normally perform reviews to verify activities
were conducted in accordance with requirements. Such oversight may have
prevented this problem, or detected it sooner. Given the seriousness of
these violations, the involvement of the NMT Supervisor, and the RSO's
failure to detect record keeping problems, the violations have been classified
in the aggregate as a Severity Level III problem in accordance with the
"General Statement of Policy and Procedure for NRC Enforcement Actions"
(Enforcement Policy), NUREG-1600.

In accordance with the Enforcement Policy, a base civil penalty in the
amount of $2,750 is considered for a Severity Level III violation. Because
Windham Hospital has not previously been the subject of an escalated enforcement
action, the NRC considered whether credit was warranted for Corrective
Action in accordance with the civil penalty assessment process in
Section VI.B.2 of the Enforcement Policy. Credit for corrective actions
is warranted because once you identified the violation, your corrective
actions were prompt and comprehensive. These actions, which were described
at the conference, included the disciplinary actions against staff personnel;
replacement of the RSO; and establishment of a new policy regarding the
appropriate methods for creating and revising records.

Therefore, consistent with the enforcement policy, to emphasize the importance
of appropriate corrective actions, I have decided, after consultation
with the Director, Office of Enforcement, not to propose a civil penalty
in this case. But for your corrective actions, the NRC would have considered
a civil penalty in this case.

The other three violations (Violations B, C, and D in the Notice) are
also described in the Notice and are classified at Severity Level IV.

You are required to respond to this letter and should follow the instructions
specified in the enclosed Notice when preparing your response. In addition
to addressing the specific violations, your response also should address
the issue of increasing management oversight of your licensed program.
The NRC will use your response, in part, to determine whether further
enforcement action is necessary to ensure compliance with regulatory requirements.

In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy
of this letter and its enclosure, will be placed in the NRC Public Document
Room (PDR). Your cooperation with us is appreciated.

Sincerely,

Hubert J. Miller
Regional Administrator

Docket No. 030-08728
License No. 06-15203-01

Enclosure: Notice of Violation

cc w/encl:
State of Connecticut

NOTICE OF VIOLATION

Windham Memorial Hospital
Willimantic, Connecticut

Docket No. 030-08728
License No. 06-15203-01
EA 97-392

During an NRC inspection conducted on July 21-22, 1997 at the licensee's
facility in Willimantic, Connecticut, and continued in the Region I office
on August 6, 1997, violations of NRC requirements was identified. In accordance
with the "General Statement of Policy and Procedure for NRC Enforcement
Actions," (Enforcement Policy, NUREG 1600, the violations are set
forth below:

A. 10 CFR 30.9(a) states, in part, that information required
by the Commission's regulations to be maintained by the licensee shall
be complete and accurate in all material respects.

1. 10 CFR 35.50 requires, in part, that each licensee shall
test each dose calibrator for constancy with a dedicated test source at
the beginning of each day of use and that the licensee retain a record
of each test required by 10 CFR 35.50 for three years unless directed
otherwise.

Contrary to the above, between March 10 and May 12, 1997, information
required by the Commission's regulations to be maintained by the licensee
was not complete and accurate in all material respects, in that constancy
tests of the dose calibrator with the cobalt-57 source were not conducted;
however, entries were made in the dose calibrator constancy record to
indicate that the tests were performed. Specifically,

a. a test value of 325 microcuries was recorded by a Nuclear
Medicine Technologist (NMT) for all dates between March 10, 1997,
and May 12, 1997, even though the tests were not performed;
and,

b. sometime in May 1997, after the NMT Supervisor returned from
extended leave and recognized that the cobalt-57 dose calibrator constancy
test results were outside the acceptable range, the NMT revised his previous
entries (using white out or writing over) by creating new test results
that were within the acceptable range. (01013)

2. 10 CFR 35.92(b) requires a record of each disposal permitted
under 10 CFR 35.92, "Decay-in-storage." The record must include, in part,
the date of the disposal and the date on which the byproduct material
was placed in storage.

Contrary to the above, sometime in May 1997, after the NMT Supervisor
returned from extended leave, the NMT Supervisor created inaccurate records
of dates to document the disposal of radioactive aerosol kits that had
been held for decay-in-storage during the period when he was on leave.
The NMT supervisor did not have first-hand knowledge of the actual dates
because the dates occurred during the period when he was on extended leave.
(02013)

B. 10 CFR 35.22(a)(3) requires that to establish a quorum and
conduct business, at least one half of the Radiation Safety Committee's
membership must be present, including the Radiation Safety Officer and
management's representative.

Contrary to the above, on September 24, 1996, the licensee's
Radiation Safety Committee met and conducted business, and a quorum was
not established in that less than one half of the committee's membership
were present. (02014)

This is a Severity Level IV violation (Supplement VI).

C. 10 CFR 35.75(a) requires, in part, that a licensee not authorize
release from confinement for medical care any patient administered a radiopharmaceutical
until the measured dose rate from the patient is less than 5 millirems
per hour (mr/hr) at a distance of one meter (1997 revision not applicable).

Contrary to the above, on May 11, June 12, and September 8,
1995, the licensee released patients from confinement without first measuring
the dose rate at a distance of one meter from these patients to ensure
that the measured dose rates were below 5 millirems per hour. Specifically,
the licensee released patients who had received 30 millicuries of sodium
iodide iodine-131 on May 11, June 12, and September 8, 1995, and, at the
time of release, the licensee did not measure the dose rate at one meter
from the patients. (03014)

This is a Severity Level IV violation (Supplement VI).

D. Condition 15 of License No. 06-15203-01 requires the licensee
to conduct its program in accordance with the statements, representations,
and procedures contained in License Application dated July 26, 1995.

Item 10.4 of the License Application states, that the licensee
will comply with the model procedures of Appendix I of Regulatory Guide
10.8, Revision 2.

Item 5 of Appendix I requires, that personnel are not to eat,
drink, smoke, or apply cosmetics in any area where radioactive material
is stored or used.

Contrary to the above, the licensee did not conduct its program
in accordance with the statements, representations, and procedures contained
in License Application dated July 26, 1995. Specifically, on July 21,
1997, the inspector observed evidence of drinking in the cardiac stress
lab in that there were several cups containing water and ice, and a trash
can containing two tea bags, and licensee staff acknowledged that these
items belonged to them. (04014)

This is a Severity Level IV violation (Supplement VI).

Pursuant to the provisions of 10 CFR 2.201, Windham Hospital is hereby
required to submit a written statement or explanation to the U.S. Nuclear
Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555,
with a copy to the Regional Administrator, Region I, within 30 days of
the date of the letter transmitting this Notice of Violation (Notice).
This reply should be clearly marked as a "Reply to a Notice of Violation"
and should include for each violation: (1) the reason for the violation,
or, if contested, the basis for disputing the violation, (2) the corrective
steps that have been taken and the results achieved, (3) the corrective
steps that will be taken to avoid further violations, and (4) the date
when full compliance will be achieved. Your response may reference or
include previous docketed correspondence, if the correspondence adequately
addresses the required response. If an adequate reply is not received
within the time specified in this Notice, an Order or a Demand for Information
may be issued as to why the license should not be modified, suspended,
or revoked, or why such other action as may be proper should not be taken.
Where good cause is shown, consideration will be given to extending the
response time.

If you contest this enforcement action, you should also provide a copy
of your response to the Director, Office of Enforcement, United States
Nuclear Regulatory Commission, Washington, D.C. 20555-0001.

Under the authority of Section 182 of the Act, 42 U.S.C. 2232, this response
shall be submitted under oath or affirmation.

Because your response will be placed in the NRC Public Document Room
(PDR), to the extent possible, it should not include any personal privacy,
proprietary, or safeguards information so that it can be placed in the
PDR without redaction. If personal privacy or proprietary information
is necessary to provide an acceptable response, then please provide a
bracketed copy of your response that identifies the information that should
be protected and a redacted copy of your response that deletes such information.
If you request withholding of such material, you must specifically
identify the portions of your response that you seek to have withheld
and provide in detail the bases for your claim of withholding (e.g., explain
why the disclosure of information will create an unwarranted invasion
of personal privacy or provide the information required by 10 CFR 2.790(b)
to support a request for withholding confidential commercial or financial
information). If safeguards information is necessary to provide an acceptable
response, please provide the level of protection described in 10 CFR 73.21.